Special feature: GS1 Healthcare Conference in Seoul U.S. - Get ready for UDI UDI aims at establishing a single device identification system that is consistent, unambiguous, standardised and globally harmonised. The U.S. Food and Drug Administration (FDA) published its regulation in September 2013 and is setting up a phased implementation plan based on a risk-based approach. • The first compliance deadline will be 24 September 2014, focusing on high-risk devices (“Class III” devices under the FDA classification). • The second compliance deadline will be 24 September 2015 for life supporting and life sustaining devices, followed by 24 September 2016 for the rest of Class II devices. • Class I devices will have to be labelled and registered with a UDI by 24 September 2018. The FDA will allow some case-by-case exemptions.
As the deadline is getting very close for Class III devices, Jay Crowley insisted in Seoul that “Class III and PHS Act devices need to comply with the UDI Rule by 24 September 2014”. The UDI system has the potential to improve medical device adverse events reporting, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety. The FDA has worked closely with the U.S. Healthcare industry, the Healthcare providers and patient groups in the development of this rule. In December 2013, GS1 became the first issuing agency approved by the U.S. FDA for unique device identifiers (UDIs). Global GS1 Standards meet the government’s criteria for UDIs and will help manufacturers comply with the requirements of the new FDA UDI regulation, to support patient safety and supply chain security. During the Global GS1 Healthcare conference in Seoul, Jay Crowley (formerly Senior Advisor at the U.S. FDA and main author of the UDI rule) presented the new legislation and explained in detail what device manufactures and labellers needed to do to comply with the rule.
“Class III and PHS Act devices need to comply with the UDI Rule by 24 September 2014”.
www.gs1.org/healthcare - GS1 Healthcare Newsletter N°29 - Q1 - 2014